Assessment of Customized Bimodal Stimulation for Tinnitus

Eligibility Criteria

• * 18 years and over at time of consent
• * Ability to read and understand English
• * Willing and able to provide and understand informed consent
• * Willing to commit to the full duration of the investigation
• * Subjective tinnitus
• * Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
• * Baseline Tinnitus Handicap Inventory (THI) score from 38 to 100
• * Access to reliable internet connection and device to complete virtual video visits and electronic surveys
• * Tonal tinnitus that can be matched
• * Subjective tinnitus, where pulsatility is the dominant feature
• * Objective tinnitus
• * Middle ear pathology in either ear including documented/known conductive hearing loss \>= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed.
• * Began wearing hearing aids within the past 3 months
• * Hearing loss of greater than 80 dB HL in any test frequency in the set {2k,3k,4k,6k,8k} Hz or greater than 40 dB HL in the set {250,500,1k} Hz either unilaterally or bilaterally
• * Health care provider has rendered a diagnosis of Meniere's disease or other disorder with fluctuating hearing loss
• * A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered
• * History of auditory hallucinations
• * Tumor on the hearing or balance nervous systems
• * Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
• * Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for a list of medical treatments.
• * Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for a list of medical treatments.
• * Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for a list of medical treatments.
• * Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
• * Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
• * Participant with a pacemaker or other electro-active implanted device
• * Participant previously diagnosed with psychosis or schizophrenia
• * Participants diagnosed with Burning Mouth Syndrome
• * A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
• * Previous involvement in a clinical investigation for tinnitus treatment within the previous 3 months or had an implantable or surgical intervention for tinnitus
• * Inability to physically or comprehensively use the device
• * Oral piercings that cannot or will not be removed
• * Pregnancy per patient report
• * Prisoner
• * Principal Investigator (PI) does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.